Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Sr. Regulatory Affairs Manager
Summary:
The Sr. Regulatory Affairs Manager will support global regulatory activities for pharmaceutical products and ensure compliance with applicable regulatory requirements.
Responsibilities:
- Develop and execute regulatory strategies for product lifecycle activities.
- Prepare and review regulatory submissions and documentation.
- Support communications with regulatory agencies globally.
- Ensure compliance with FDA, EMA, and international regulatory requirements.
- Collaborate cross-functionally with Quality, Manufacturing, R&D, and Supply Chain teams.
- Support change controls and regulatory impact assessments.
Qualifications:
- Bachelor’s degree in Life Sciences or related field.
- 8+ years of Regulatory Affairs experience in pharmaceutical manufacturing.
- Strong knowledge of FDA and EMA regulations.
- Experience supporting global submissions and post-approval changes.
- Excellent communication and project management skills.
At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
Skills Required
- Bachelor's degree in Life Sciences or related field
- 8+ years of Regulatory Affairs experience in pharmaceutical manufacturing
- Strong knowledge of FDA and EMA regulations
- Experience supporting global submissions and post-approval changes
- Excellent communication and project management skills
What We Do
Pinnaql, Inc. is a professional services consulting firm providing quality, regulatory, and operational excellence solutions to biopharmaceutical, medical device, and CDMO companies worldwide. The company specializes in laboratory validation, engineering, and compliance, helping regulated life sciences organizations navigate manufacturing challenges, reduce execution risks, and accelerate the transition from lab innovation to commercial market readiness.
